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The InThrill™ Thrombectomy System is indicated for: - The non-surgical removal of emboli and thrombi from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft. The InThrill™ Sheath is indicated for use as a conduit for the insertion of endovascular devices into the peripheral vasculature while minimizing blood loss associated with such insertions. The InThrill™ Thrombectomy System is intended for use in the peripheral vasculature. The InThrill™ Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.

The InThrill™ Thrombectomy System is a single-use, over-the-wire, catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. The system comprises two main components packaged separately: - InThrill Sheath (8 Fr) - InThrill Thrombectomy Catheter (8 Fr) The InThrill Sheath is placed in the target vessel, and, after its funnel is expanded, the InThrill Catheter is inserted through the sheath and advanced past the thrombus. The InThrill Catheter coring element is deployed, providing wall-to-wall contact to engage the clot, and is then retracted into the InThrill Sheath to capture the targeted thrombus. Additional clot may be removed by aspiration through the sheath with a syringe (not provided). After the procedure is complete, the InThrill Catheter and InThrill Sheath are removed from the patient.

The FlowTriever2 Catheter is indicated for: • The non-surgical removal of emboli and thrombi from peripheral blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever2 Catheter is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism (PE).

The Inari FlowTriever Retrieval/Aspiration System is a single-use, sterile medical device comprised of the following components, each packaged separately: • FlowTriever2 Catheter - Model 11-102 • Triever20® - Model 21-101 • Triever24® - Model 22-101 • Triever16® - Model 25-101 The FlowTriever2 Catheter is used to engage and retrieve emboli and thrombi. It consists of a coaxial catheter assembly with an outer Delivery Catheter and an inner catheter having a flexible shaft attached to distal self-expanding wireform element. A "Y" connector with a rotatable hemostatic valve and stopcock is attached to the proximal end of the outer Delivery Catheter. Radiopaque markers are positioned near the distal tip of the Delivery Catheter and at the proximal and distal ends of the self-expanding FlowTriever element to aid with fluoroscopic visualization. The Triever20 and Triever24 (packaged separately) provides a conduit for FlowTriever2 Catheter deployment, aspiration, and clot removal. It consists of a single lumen catheter with a proximal hemostasis valve and stopcock with flush port. A radiopaque marker is positioned near the distal tip to aid with fluoroscopic visualization. A Dilator compatible with a 0.035" guidewire is provided for the Triever20 and Triever24 to aid insertion. Alternatively, the Triever16 can be tracked through the Triever Catheter (20 or 24 Fr) over the pre-inserted guidewire to a location proximal to the targeted thrombus. Thrombus is removed via aspiration using the Triever16, after which it can be withdrawn and flushed to remove residual thrombus, leaving the Triever Catheter in place as a conduit for subsequent thrombectomy passes. The user may elect to perform a thrombectomy pass using the FlowTriever2 Catheter or through the Triever16 using aspiration alone. The Inari FlowTriever Retrieval/Aspiration System has not been evaluated for use in the neurovasculature.

The Artix™ MT thrombectomy device is indicated for: · The non-surgical removal of emboli and thrombi from blood vessels · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Artix™ MT thrombectomy device is intended for use in the peripheral vasculature. The Artix™ Thin-Walled Sheath is indicated for: · The non-surgical removal of emboli and thrombi from blood vessels. · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. · Use as a conduit for endovascular devices. · Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The funnel provides temporary vascular occlusion during these and other angiographic procedures. The Artix™ Thin-Walled Sheath is intended for use in the peripheral vasculature.

The Artix™ MT is a single-use, over-the-wire catheter device used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The Artix MT is packaged with the following components: Artix MT (3-6 mm or 4-8 mm) Cleaning accessory 1-Way Stopcock The Artix MT is inserted over-the-wire through a compatible sheath (such as the Artix Thin-Walled Sheath) and advanced until its proximal marker band is distal to the target thrombus. The self-expanding element is deployed by retracting the delivery catheter. Thrombus is engaged and removed by retracting the Artix MT into the sheath and out of the patient. Once the procedure is complete, the system is completely withdrawn from the patient. The Artix™ Thin-Walled Sheath ("Artix Sheath") is a single-use, over-the-wire system designed to facilitate the insertion and guidance of an intravascular catheter into a selected peripheral blood vessel and act as a conduit for endovascular devices. The Artix Sheath also non-surgically aspirates thromboemboli from selected vessels and is capable of infusion/aspiration of fluids into or from a selected vessel. The Artix Sheath is packaged with the following components: Artix Thin-Walled Sheath (65 cm or 90 cm) Sheath Dilator (0.035" guidewire compatibility) Funnel Catheter and Funnel Catheter Dilator (0.035" guidewire compatibility) Funnel Loading Tool (2) Large Bore Syringe, 30 mL The Artix Sheath is inserted over-the-wire and advanced to a desirable position. Any compatible endovascular device, such as the Artix MT, can then be inserted through the Artix Sheath for access into the peripheral vasculature. The provided funnel catheter accessory can also be inserted through the Sheath and deployed to provide flow occlusion of the vessel during the procedure to aid with the system's clot ingestion. Compatible endovascular devices, such as the Artix MT, can be used through the 6 Fr inner diameter of the funnel catheter as well. The provided 30 mL syringe can be used to aspirate clot in the vessel or Sheath and infuse contrast media and other fluids as required. Once the procedure is complete, the funnel catheter (if used) is removed prior to withdrawal of the entire system from the patient, and standard 7 Fr closure devices can be used.

The ClotTriever Thrombectomy System is indicated for: - · The non-surgical removal of thrombi and emboli from blood vessels. - · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).

The ClotTriever Thrombectomy System is a single-use, sterile medical device system designed to remove thrombi and emboli from the peripheral vasculature. The ClotTriever XL Catheter is intended for vessels 10 to 28 mm in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the 16Fr ClotTriever Sheath ("ClotTriever Sheath"), Protrieve Sheath and the ClotTriever XL Catheter ("Catheter"), each packaged separately. The ClotTriever XL Catheter is a coaxial catheter assembly with a distal coring element and collection bag for retrieving thrombus. The proximal handle controls the expansion of the collection bag via the inner catheter. The outer shaft constrains the coring element and collection bag prior to deployment. Stopcocks and Luer connectors are provided for de-airing the ClotTriever XL Catheter shafts. To aid in fluoroscopic visualization, the distal tip is radiopaque and radiopaque marker bands are located on the intermediate catheter to identify the proximal end of the coring element, and on the outer catheter to identify the distal end of ClotTriever XL outer catheter.

The Removal System Large Bore 60 cc Syringe is used with the Removal Catheters to inject fluids into or withdraw fluids and/or tissues from the body. It can be used for aspiration removal of fluid and/or tissue in the form of abscess fluid, infected materials, etc.

The Removal System Large Bore 60 cc Syringe is a general piston syringe constructed using a barrel, plunger, plunger seal, and large bore Toomey tip adapter that acts as a quick-release connector. The quick-release connector is compatible with the Removal System Catheters' sideport connector to establish an airtight seal. The twist-to-lock plunger with barrel tabs maintains the retracted position of the plunger.

The VenaCore Thrombectomy Catheter is indicated for: · The non-surgical removal of thrombi and emboli from blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels. The VenaCore Thrombectomy Catheter is intended for use in the peripheral vasculature.

The VenaCore Thrombectomy Catheter is a single-use, sterile, over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The VenaCore Thrombectomy Catheter is designed to remove thrombi and emboli in the peripheral vasculature. The VenaCore Thrombectomy Catheter consists of a distal laser-cut nitinol coring element, three coaxial catheter shafts (inner, middle, and outer), and a handle with a diameter control knob and a lever. The proximal handle controls the expansion and collapse of the coring element via the handle knob and lever. The outer shaft constrains the coring element prior to deployment. To aid in fluoroscopic visualization, the distal tip is radiopaque, and a radiopaque tip is located on the outer catheter to identify the distal end of the outer catheter.

The ClotTriever Thrombectomy System is indicated for: • The non-surgical removal of thrombi and emboli from blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). The ClotTriever Sheaths are indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

The ClotTriever Thrombectomy System ("ClotTriever System") is a single-use over-the-wire catheter-based system used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system consists of ClotTriever Catheters, ClotTriever Sheaths and Protrieve Sheath, each packaged separately. The ClotTriever Sheath consist of a polymeric shaft with a distal self-expanding nitinol mesh funnel, a proximal hub with a hemostasis valve and a sideport tubing. The mesh funnel is deployed by retracting the slide actuator back until it snaps into place. The mesh funnel self-expands to the diameter of the vessel and serves as a backstop as clot is removed through the lumen of the sheath. A hemostasis valve is integrated into the proximal hub of the sheath to prevent blood loss from devices passing through it. The sideport tubing has a large-bore stopcock and a terminal quick-disconnect coupling for connection to the Large Bore 60 cc Syringe for the aspiration of clot. A pre-dilator is provided with the ClotTriever Sheaths, to expand the target vessel prior to sheath insertion. A dilator is provided to aid insertion and positioning of the sheath, while the loading tool facilitates insertion of the mesh funnel into the dilator.

The Intri24 Introducer Sheath is indicated to provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

The Intri24 Introducer Sheath is a single-use over-the-wire system intended for use in vessels > 9 mm and is a conduit for the insertion of diagnostic or endovascular devices into the peripheral vasculature. The Intri24 Introducer Sheath consists of a Sheath and Dilator. The Sheath is comprised of a single lumen catheter with a hydrophilic coating, a proximal hemostasis valve, and stopcock with flush port. A radiopaque marker is positioned near the distal tip of the sheath to aid with fluoroscopic visualization. The Dilator is 0.035" guidewire compatible and attaches to the hemostasis valve on the Sheath. The Dilator has a tapered edge to aid in the dilation of the target vessel for insertion and positioning of the Sheath.

The Talon Transseptal Sheath is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation/puncture.

The Talon Transseptal Sheath (“Sheath”) provides a conduit for catheterization and angiography of specific heart chambers and locations. It consists of a single lumen catheter with a proximal hemostasis valve and stopcock with flush port. A radiopaque marker is positioned near the distal tip to aid with fluoroscopic visualization. The Sheath is packaged with a dilator and two 60 cc syringes. The dilator is compatible with a 0.035" guidewire and has a tapered tip which aids insertion and positioning of the Sheath. The dilator attaches to the Sheath hemostasis valve, and a Y-connector with hemostasis valve connects to the dilator luer connector. A quick-release syringe is provided to connect to the Sheath sideport, and a standard VacLok syringe is provided to connect to the Sheath flush port and dilator connector.

The Triever20 Curve (21-201) is used coaxially within the Triever24 for: • The non-surgical removal of emboli and thrombi from blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Triever20 Curve (21-201) is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. The Triever20 Curve (21-201) Catheter is not indicated for use with FlowTriever Catheters. Triever20 Curve (21-201) is also intended for use in treating clot in transit in the right atrium, but not in conjunction with FlowTriever Catheters. The Triever20 Curve (21-201) must be used within the Triever24.

Triever20 Curve, Model 21-201 is a single-use over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature and the treatment of pulmonary embolism. A Dilator is provided with the Triever20 Curve Catheter to assist in its advancement over a preplaced 0.035" guidewire to the proximal end of the obstruction (thrombus). The Triever24 Catheter is inserted through an introducer sheath (not provided). After Triever24 Catheter placement, the Dilator is removed. The Triever20 Curve Catheter is then inserted through the Triever24 Catheter and advanced to the thrombus. Thrombus is removed by aspiration with the provided 60 cc Large Bore Syringe.